Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:14 AM
Ignite Modification Date: 2025-12-26 @ 3:13 AM
NCT ID: NCT02093520
Description: For standardization of reporting, all adverse events have been coded by an outside agency into MedDRA System Organ Class and Preferred Term classifications
Frequency Threshold: 0
Time Frame: None
Study: NCT02093520
Study Brief: The MiDAS ENCORE Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Minimally Invasive Lumbar Decompression (MILD) Image guided minimally-invasive lumbar decompression Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue. 2 None 18 149 2 149 View
Epidural Steroid Injection (ESI) An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine. Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine 0 None 13 153 2 153 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory, thoracic and mediastinal disorders None Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Surgical and medical procedures None Surgical and medical procedures MedDRA (18.0) View
Cardiac Disorders None Cardiac disorders MedDRA (18.0) View
Gastrointestinal Disorders None Gastrointestinal disorders MedDRA (18.0) View
General disorders and administration site conditions None General disorders MedDRA (18.0) View
Infections and infestations None Infections and infestations MedDRA (18.0) View
Injury, poisoning and procedural complications None Injury, poisoning and procedural complications MedDRA (18.0) View
Musculoskeletal and connective tissue disorders None Musculoskeletal and connective tissue disorders MedDRA (18.0) View
Neoplasms benign, malignant and unspecifie None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
Nervous system disorders None Nervous system disorders MedDRA (18.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injury, poisoning and procedural complications None Injury, poisoning and procedural complications MedDRA (18.0) View
Cardiac disorders None Cardiac disorders MedDRA (18.0) View
Musculoskeletal and connective tissue disorders None Musculoskeletal and connective tissue disorders MedDRA (18.0) View